four pa.qes) ..................... 12 Other Biographical Sketches (Not to exceed four pages for each - See instructions)) ............................ 15 Resources ........................................................................................................................................................ 42 Research Plan Introduction to Revised Application (Notto exceed 3 pages) ................................................................................................................ Introduction to Supplemental Application (Not to exceed one page) ..................................................................................................... 48 A. Specific Aims ............................................................................ ._. ......................................................................................... 48 B. Background and Significance ................................................... .....|. ........................................................................................ I 57 C, Preliminary Studies/Progress Report/ _ (Items A-D: not to exceed 25 pages*) "_t Phase I Progress Report (SBIR/STTR Phase II ONLY) F SBIR/STTR Phase l: ltems A-D limited t[unreadable]15 pages I [3. Research Design and Methods ................................................ _ .......................................................................................... 62 E. Human Subjects .......................................................................................................................................................................... 73 Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ...................................................................... Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") .................................................................... Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ...................................................................... Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" anda Phase I, II, or III clinical trial is proposed ............................................................................................................................................................... F. Vertebrate Animals ...................................................................................................................................................................... G. Literature Cited ............................................................................................................................................................................ 82 H. Consortium/Contractual Arrangements ....................................................................................................................................... I. Letters of Support (e.g., Consultants) ......................................................................................................................................... 96 J. Product Development Plan (SBIRISTTR Phase II and Fast-Track ONLY) ............................................................................... Checklist ........................................................................................................................................................... 102 Check if Appendix (Five collated sets. No page numbering necessary for Appendix.) Appendix is Included Appendices NO T PERMITTED for Phase I SBIR/S TTR unless specifically solicited. Number of publications and manuscdpts accepted for publication (not to exceed 10) Other items (list): Appendix I Color Plates of Figures in Preliminary Studies PHS 398 (Rev. 05/01) Page 3 Form Page 3